ArticleFrontiers in psychiatry2025
Gender-stratified 9-month comparison of paliperidone extended-release tablets and paliperidone palmitate injection in schizophrenia.
Article in Frontiers in psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Gender differences in antipsychotic efficacy for schizophrenia (SCZ) remain understudied despite evidence of sex-dependent pharmacokinetic, neurobiological, and social factors influencing outcomes. This trial compared 9 - month efficacy and tolerability of paliperidone palmitate injection 1-monthly (PP1M) versus extended-release tablets in male and female patients with SCZ, with a focus on gender-stratified results. Methods: This randomized, open-label study enrolled 118 adult patients (61 males, 57 females) diagnosed with SCZ. Participants were randomized (1:1) to receive either paliperidone extended-release (ER) tablets (titrated 3-12 mg/day) or PP1M (3-9 mg monthly). Efficacy was assessed via PANSS total scores and CGI-S severity ratings at 3, 6, and 9 months. Safety was evaluated using the TESS scale. Results: Gender-stratified analysis revealed superior long-term efficacy for males treated with paliperidone palmitate injection. Males treated with PP1M demonstrated significantly greater reductions in PANSS scores (mean difference at 9 months: -7.44; p < 0.05) and CGI-S severity compared to ER therapy. Females showed no statistically significant differences between formulations at any time point, with overlapping confidence intervals (e.g., PANSS mean difference at 9 months: +3.16; p > 0.05). Both groups exhibited comparable tolerability, with minimal adverse events. Conclusion: Gender-informed treatment strategies are critical in SCZ management. PP1M appears advantageous for males seeking long-term symptom stabilization, while treatment selection for females may prioritize lifestyle factors. These findings underscore the need for sex-stratified analysis in antipsychotic trials and the importance of tailored interventions to address sex-based disparities in psychiatric care.
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